CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 40 enrolled
Drug / intervention
Fiasp® +2 moredrug
Likely dose
670G hybrid closed loop continuous subcutaneous insulin infusion systemfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03977727
NCT03977727Phase 3Completed

An Exploratory, Single-center, Randomized, Open Label, Active-control, Cross-over Trial Comparing the Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart (Fiasp®) Compared to NovoLog® Used in the Medtronic 670G Closed Loop System in Adults With Type 1 Diabetes

Texas Diabetes & Endocrinology, P.A.·interventional·Posted Jun 6, 2019·Updated Sep 29, 2020

In Brief

A Phase 3 clinical trial evaluating Fiasp®, Novolog®, and 1 other intervention for Type 1 Diabetes Mellitus. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This is an exploratory, single-center, randomized, open label, active-controlled, complete cross-over trial comparing safety and efficacy of Fiasp® versus NovoLog® when used in the Medtronic MiniMed 670G system in subjects with T1DM.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJun 6, 2019
Enrollment StartJun 11, 2019
Primary CompletionMar 9, 2020
Study CompletionApr 20, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.1 years ago

Interventions

Fiasp®drug

Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system

Novolog®drug

Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system

670G hybrid closed loop continuous subcutaneous insulin infusion systemdevice

CSII